Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
研究概览
简要总结
The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:
- The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
- The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.
The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:
Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.
Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
- •Resident in Stockholm County
排除标准
- •Lack of understanding of the Swedish language.
- •Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
- •Doctor's assessment that there is a need for medication for alcohol dependence.
研究组 & 干预措施
Internet-based treatment
A five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
干预措施: Guide to better alcohol habits (Behavioral)
Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
干预措施: Guide to better alcohol habits (Behavioral)
结局指标
主要结局
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
时间窗: 3 months post-randomization
次要结局
- Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method(24 months post-randomization)
- Alcohol Use Disorders Identification Test score(24 months post-randomization)
- Number of criteria for alcohol dependence according to International Classification of Diseases - 10(24 months post-randomization)
- Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V(24 months post-randomization)
- Number of days absent from work due to illness(24 months post-randomization)
- Score on Montgomery-Åsberg Depression Rating Scale(24 months post-randomization)
- Score on Generalised Anxiety Disorder 7-item scale(24 months post-randomization)
- Score on EQ-5D measuring the quality of life(24 months post-randomization)
- Cost for treatment(24 months post-randomization)
研究者
Kristina Sinadinovic
PhD
Karolinska Institutet